Dry Eye SyndromesPhase 2NCT00788229
Efficacy and Safety Study of ATs in Patients With Dry Eye Syndrome
A Phase 2 study testing AT01, AT02 and AT03 in people with Dry Eye Syndromes and Keratoconjunctivitis Sicca, run by Dhp Korea Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether artificial tears are safe and effective in the treatment of Dry Eye Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
- What is being tested?
- AT01, AT02 and AT03
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2008to Aug 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adults aged 18 years and over.
- Subjects should diagnosed as dry eye syndrome in both eyes or one eye, keratoconjunctivitis sicca (KCS), or should have at least a 3-month history diagnosed as dry eye syndrome due to Sjögren syndrome.
- Subjects must agree to discontinue all artificial tears from Screening for 2 weeks
- Subjects must discontinue lens wear one week before Screening and agree not to wear contact lenses during the entire study.
- Subjects who have taken Restasis® are eligible for inclusion if they have not used Restasis® during the 4 weeks prior to Screening
- Subjects must provide signed informed consent prior to participation in any study-related procedures
- Subjects who dose not Participate in same clinical trial within 6 month prior to Screening.
Who cannot join
- Pregnancy or lactation.
- Females of childbearing potential who are not using systemic contraception,are not postmenopausal (≥ 1 year), or are not surgically sterilized.
- Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening.
- Any active inflammation of the eye not due to KCS
- Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study medication.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan medical center
Seoul, 388-1 Pungnap-2dong, Songpa-gu, 138-736
About this study
Official title: A Phase II, Randomized, Double-Blind, Clinical Trial to Evaluate the Efficacy and Safety of DHP-101, DHP-300, DHP-500 in Patients With Dry Eye Syndrome
The purpose of this study is to determine whether artificial tears are safe and effective in the treatment of Dry Eye Syndrome.
- Conditions
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
- Being tested
- AT01, AT02, AT03, AT04
- Keywords
- Dry Eye Syndromes, Keratoconjunctivitis Sicca, artificial tears, carboxymethylcellulose sodium, sodium hyaluronate
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT01Drug
Also called DHP-101
eye drop for 12 weeks
AT02Drug
Also called DHP-300
eye drop for 12 weeks
AT03Drug
Also called DHP-500
eye drop for 12 weeks
AT04Drug
Also called Saline
eye drop for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1. Study Drugs | Experimental | Not described Receives: Drug: AT01 |
| 2. Study Drug | Experimental | Not described Receives: Drug: AT02 |
| 3. Study Drug | Experimental | Not described Receives: Drug: AT03 |
| 4. Placebo | Placebo comparator | Not described Receives: Drug: AT04 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Break Up Time (TBUT)
Measured: 12weeks
Secondary outcomes (1)
Fluorescein staining, schirmer test, OSDI, VAS
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dhp Korea Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hungwon Tchah,, MD, Principal investigator, Seoul asan medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788229
- Sponsor's protocol ID
- dhpat02
- Status last verified
- Apr 2010
- First submitted
- 7 Nov 2008
- Last updated
- 2 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Clinical Trial to Evaluate the Efficacy and Safety of DHP-101, DHP-300, DHP-500 in Patients With Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT00788229
- Acronym / sponsor ID
- dhpat02
- Conditions
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
- Keywords
- Dry Eye Syndromes, Keratoconjunctivitis Sicca, artificial tears, carboxymethylcellulose sodium, sodium hyaluronate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Dhp Korea Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 10 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether artificial tears are safe and effective in the treatment of Dry Eye Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1. Study Drugs | Experimental | Drug: AT01 |
| 2. Study Drug | Experimental | Drug: AT02 |
| 3. Study Drug | Experimental | Drug: AT03 |
| 4. Placebo | Placebo comparator | Drug: AT04 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female adults aged 18 years and over.
- Subjects should diagnosed as dry eye syndrome in both eyes or one eye, keratoconjunctivitis sicca (KCS), or should have at least a 3-month history diagnosed as dry eye syndrome due to Sjögren syndrome.
- Subjects must agree to discontinue all artificial tears from Screening for 2 weeks
- Subjects must discontinue lens wear one week before Screening and agree not to wear contact lenses during the entire study.
- Subjects who have taken Restasis® are eligible for inclusion if they have not used Restasis® during the 4 weeks prior to Screening
Key exclusion criteria (5 listed)
- Pregnancy or lactation.
- Females of childbearing potential who are not using systemic contraception,are not postmenopausal (≥ 1 year), or are not surgically sterilized.
- Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening.
- Any active inflammation of the eye not due to KCS
- Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AT01Also: DHP-101eye drop for 12 weeks | Drug | 1. Study Drugs |
| AT02Also: DHP-300eye drop for 12 weeks | Drug | 2. Study Drug |
| AT03Also: DHP-500eye drop for 12 weeks | Drug | 3. Study Drug |
| AT04Also: Salineeye drop for 12 weeks | Drug | 4. Placebo |
Primary outcome
Tear Break Up Time (TBUT)
Time frame: 12weeks
1 secondary outcome
Fluorescein staining, schirmer test, OSDI, VAS
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hungwon Tchah,, MD principal investigator
Seoul asan medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AT01, AT02 and AT03 in people with Dry Eye Syndromes and Keratoconjunctivitis Sicca, run by Dhp Korea Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear Break Up Time (TBUT) (time frame: 12weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2010.